Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Conditions: Keywords
ED-SCLC, small cell lung cancer, CPT-11, irinotecan hydrochloride, CDDP, cisplatin, PSK, Krestin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Irinotecan hydrochloride Type: Drug
Name: Cisplatin Type: Drug
Name: Krestin Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer.
Detailed Description
To examine whether the following protocol and regimen is appropriate for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer: set test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation, evaluate the efficacy and safety of treatment in a small number of cases, and compare with historical control or community control.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with histologically or cytologically proven small cell lung cancer

- Patients receiving chemotherapy for the first time

- Patients with no indication for radical radiotherapy or surgical resection

- Patients diagnosed as ED* by full staging [chest X ray, chest C, brain CT or MRI, abdominal CT or abdominal ultrasonography, whole body bone scintigraphy (may be replaced by PET/CT)]

- ED: Patient with distant metastasis including contralateral hilar lymph node metastasis, but ipsilateral pleural effusion without distant metastasis is excluded.

- Patients with lesions measurable or evaluable by the RECIST criteria

- Patients aged from 20 years to below 75 years

- Patients with preserved organ functions as indicated by the following test values (data obtained within 14 days prior to registration) Hemoglobin: ≥9.0 g/dL White blood cell count: ≥4,000/mm3, ≤12,000 /mm3 Neutrophil count: ≥ 2,000/mm3 Platelet count: ≥100,000 /mm3 GOT, GPT: below 2.5 times the upper limit of normal range for individual facility Total bilirubin: ≤1.5 mg/dL Serum creatinine: below the lower limit of normal range for individual facility Creatinine clearance: ≥ 60mL/min Arterial oxygen tension (PaO2): ≥60 torr (resting)

- Performance status (PS): 0-1

- Absence of serious concurrent cardiac or pulmonary disease

- Patients expected to survive for at least 3 months

- Patients from whom written informed consent can be obtained

Exclusion Criteria:

- Patients with serious infection and other serious complications (including gastrointestinal bleeding and diarrhea)

- Patients with pleural effusion, ascites, or pericardial effusion that requires treatments including puncture drainage and intracavity administration

- Patients showing definite interstitial pneumonitis or pulmonary fibrosis on plain chest radiograph

- Patients manifesting central nervous system symptoms due to brain metastasis at registration

- Patients with active multiple cancers

- Patients who had undergone bone marrow transplantation

- Patients who had undergone peripheral blood stem cell transplantation

- Patients with a history of definite drug allergy

- Pregnant and nursing patients, patients who may be pregnant or who intend to become pregnant

- Male patients with reproductive capacity who have no intention of contraception during the clinical trial

- Patients with poorly controlled diabetes

- Patients who had been administered Krestin in the past

- Others: patients who are judged by the investigator or subinvestigator to be unsuitable as subject
Locations
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Status: Recruiting
Contact: Ryoji Kato, MD - +81-43-462-8811 - ryochan@sakura.med.toho-u.ac.jp
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Satoshi Oizumi, MD - +81-11-716-1161 - soizumi@med.hokudai.ac.jp
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan
Status: Recruiting
Contact: Kazuo Kasahara, MD - +81-076-265-2000 - kasa1237@med3.m.kanazawa-u.ac.jp
Kanazawa Medical University Hospital
Uchinada, Ishikawa, Japan
Status: Recruiting
Contact: Hirohisa Toga, MD - +81-76-286-3511 - toga-h@kanazawa-med.ac.jp
Kinkidaigakuigakubu Nara Hospital
Ikoma, Nara, Japan
Status: Recruiting
Contact: Toshio Shimizu, MD - +81-743-77-0880 - tshimizu@nara.med.kindai.ac.jp
Kurashiki Central Hospital
Kurashiki, Okayama, Japan
Status: Recruiting
Contact: Hiroshige Yoshioka, MD - +81-86-422-0210 - hirotin@kchnet.or.jp
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, Japan
Status: Recruiting
Contact: Tomonori Hirasima, MD - +81-957-2121 - hirashima@opho.jp
Kinkidaigakuigakubu Sakai Hospital
Sakai, Osaka, Japan
Status: Not yet recruiting
Contact: Minoru Takada, MD - +81-72-299-1120 - m-takada@sakai.med.kindai.ac.jp
NHO Kinki-chuo Chest Medical Center
Sakai, Osaka, Japan
Status: Recruiting
Contact: Akihito Kubo, MD - +81-72-252-3021 - a-kubo@kch.hosp.go.jp
Osaka Medikal College Hospital
Takatsuki, Osaka, Japan
Status: Recruiting
Contact: Takayasu Kurata, MD - +81-72-683-1221 - ctc002@poh.osaka-med.ac.jp
Hiroshima City Hospital
Hiroshima, Japan
Status: Not yet recruiting
Contact: Yasuo Iwamoto, MD - +81-82-221-2291 - y-iwamoto@do.enjoy.ne.jp
Osaka City General Hospital
Osaka, Japan
Status: Recruiting
Contact: Koji Takeda, MD - +81-6-6929-1221 - kkk-take@ga2.so-net.ne.jp
Tokyo Medical University Hospital
Tokyo, Japan
Status: Recruiting
Contact: Masahiro Tsuboi, MD - +81-3-3342-6111 - mtsuboi@za2.so-net.ne.jp
Toyama Red Cross Hospital
Toyama, Japan
Status: Recruiting
Contact: Keiichi Iwase, MD - +81-76-433-2222 - iwasa@toyama-med.jrc.or.jp
Toyama University Hospital
Toyama, Japan
Status: Recruiting
Contact: Tatsuhiko Kashii, MD, PhD - +81-76-434-7808 - tkashii@med.u-toyama.ac.jp
Start Date
November 2007
Completion Date
September 2011
Sponsors
University of Toyama
Source
University of Toyama
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page